(40 days)
Bonding between dentin/enamel and composite filling materials Bonding between dentin/enamel and compomer filling materials Bonding mediator for fissure sealing Desensitization of hypersensitive areas of teeth Bonding between RelyX™ Fiber Post root posts and light-curing composite core build-up materials
Adper Prompt/Adper Prompt L-Pop is classified as Resin tooth bonding agent (21 C.F.R. §872.3200) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials (compomer and composite restorative material). Additionally, Adper Prompt/Adper Prompt L-Pop can be used to scal dentinal tubules of exposed root surfaces to prevent from dentinal hypersensitivity. Furthermore, as recent results show, Adper Prompt L-Pop is suited to bond RelyX™ Fiber Post, glassfiber-reinforced root canal posts by 3M ESPE, to light-curing composite core build-up materials.
The provided text does not contain specific acceptance criteria or a study design to prove that the device meets those acceptance criteria in the format requested. The document is a 510(k) summary for a dental adhesive (Adper Promote/Adper Prompt L-Pop) seeking clearance for a new indication: bonding between RelyX™ Fiber Post root posts and light-curing composite core build-up materials.
Instead of presenting quantitative acceptance criteria and a detailed study report, the document states:
- "Performance and comparative testing of Adper Prompt/Adper Prompt L-Pop has been carried out."
- "The results suggest that Adper Prompt/Adper Prompt L-Pop is a suitable agent for bonding between RelyX Fiber Post root posts, by 3M ESPE, and light-curing composite core build-up materials."
- "The data provided in this 510(k) submission shows that Adper Prompt/Adper Prompt L-Pop is substantially equivalent to the predicate devices."
The document focuses on substantiating substantial equivalence to a predicate device rather than providing a detailed performance study against predefined acceptance criteria for the new indication. Therefore, I cannot extract the information required for the table and bullet points as it is not present in the provided text.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
APR 2 4 2006
| Submitter | |
|---|---|
| Company: | 3M ESPE AG |
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number: | 9611385 |
| Official Correspondent: | Dr. Andreas Petermann, Manager Regulatory Affairs |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | andreas.petermann@mmm.com |
| Date: | March 09, 2006 |
Name of Device
| Proprietary Name: | Adper™ Prompt™ |
|---|---|
| Adper™ Prompt™ L-Pop™ | |
| Classification Name | Resin tooth bonding agent is designated at |
| 21 C.F.R. §872.3200 as a Class II device. | |
| Common Name: | Dental Adhesive |
Predicate Devices:
Adper™ Prompt™, Adper™ Prompt™ L-Pop™ by 3M ESPE (K040857) Adper™ Single Bond Plus by 3M ESPE (K962785)
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Description for the Premarket Notification
Adper Prompt/Adper Prompt L-Pop is classified as Resin tooth bonding agent (21 C.F.R. $872.3200) because it is a device intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials (compomer and composite restorative material). Additionally, Adper Prompt/Adper Prompt L-Pop can be used to scal dentinal tubules of exposed root surfaces to prevent from dentinal hypersensitivity.
Furthermore, as recent results show, Adper Prompt L-Pop is suited to bond RelyX™ Fiber Post, glassfiber-reinforced root canal posts by 3M ESPE, to light-curing composite core build-up materials. 3M ESPE submits this 510(k) premarket notification to seck clearance for this new indication for use.
Performance and comparative testing of Adper Prompt/Adper Prompt L-Pop has been carried out. The results suggest that Adper Prompt/Adper Prompt L-Pop is a suitable agent for bonding between RelyX Fiber Post root posts, by 3M ESPE, and light-curing composite core build-up materials.
The chemical composition of Adper Prompt/Adper Prompt L-Pop remained unchanged in comparison to 510(k) K040857. Performance data for Adper Prompt/Adper Prompt L-Pop in the indications for use already cleared by 510(k) are, therefore, not subject of this 510(k) submission. The data provided in this 510(k) submission shows that Adper Prompt/Adper Prompt L-Pop is substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 4 2006
Dr. Sabine Krischer Regulatory Affairs Specialist 3M ESPE AG ESPE Platz Seefeld, Bavaria D-82229 GERMANY
Re: K060684
Trade/Device Names: Adper Prompt and Adper Prompt L-Pop Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: March 09, 2006 Received: March 15, 2006
Dear Dr. Krischer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for usc stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav. therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Dr. Sabine Krischer
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suze
Chiu S. Lin, PhD
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Adper Prompt
Indications For Use:
Bonding between dentin/enamel and composite filling materials Bonding between dentin/enamel and compomer filling materials Bonding mediator for fissure sealing Desensitization of hypersensitive areas of teeth Bonding between RelyX™ Fiber Post root posts and light-curing composite core build-up materials
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
y, General Hospi
L.A. W.S
KILGORE
Page 1 of イ
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.